Mecta-C Cervical Plate System 03.70.016Recalls & reported problems
Medacta International SA · Variable self-drilling screw diam. 4x14mm (2x) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030840005), received between Oct 4, 2017 and Oct 4, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2017Break; Break
THE PATIENT CAME IN COMPLAINING OF CERVICAL PAIN. BONE SCAN AND CT SCAN WERE TAKEN, AND THE RESULTS SHOWED 2 BROKEN SCREWS ON C5 AND BONE SCAN IS POSITIVE ON C5-C6. 10 MONTHS AFTER PRIMARY THE SURGEON DECIDED TO REVISE THE PATIENT. 3 OF THE 6 PLATE SCREWS IMPLANTED IN PRIMARY WERE FOUND BROKEN (2 IN C5 AND 1 IN C7). IT WAS IMPOSSIBLE TO REMOVE THREE SCREWS DISTAL PART THAT REMAINED IN THE PATIENT. THE TWO CAGES WERE MIGRATED. IT WAS NOT POSSIBLE FOR THE SURGEON TO IMPLANT A NEW CERVICAL PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY INSERTING 2 NEW MECTA-C CAGES 1 MM THICKER THAN THE EXPLANTED. THE SURGEON COMMENTED THAT FUSION WAS DIFFICULT TO BE EVALUATED WITH THE TANTALUM MARKES.
Patient problems: Pain
MAUDE report 6913762 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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